| Date Initiated by Firm | May 04, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on November 18, 2005 |
| Recall Number | Z-0991-04 |
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| Recall Event ID |
29026 |
| 510(K)Number | K031987 |
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| Product Classification |
Automated External Defibrillators (Non-Wearable) - Product Code MKJ
|
| Product | FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143 |
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| Code Information |
The recalled Model 9143 Batteries have the following lot numbers: 7851, 7852, and 7856. |
Recalling Firm/
Manufacturer |
Cardiac Science, Inc.
1900 Main Street, Suite 700
Irvine CA 92614
|
| For Additional Information Contact | Roderick de Greef
949-797-3800 |
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Manufacturer Reason
for Recall | Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work. |
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FDA Determined
Cause 2 | Other |
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| Action | A recall letter, dated May 10, 2004, stated that a replacement battery is enclosed with the letter, and instructed consignees to install the new battery in their defibrilllator and return the old battery. |
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| Distribution | The batteries were distributed with the defibrillators nationwide in the United States and to foreign consignees in Europe, Asia, Latin America, the
Middle East and Africa.
|
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = MKJ
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